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Complaint Handling & Trending

Complaint handling is a GMP requirement under RDC 752/2022 and a core PMS activity. The complaint handling system must:

  • Record all complaints received from any source;
  • Investigate complaints to determine root cause;
  • Classify complaints as adverse events or technical complaints (for NOTIVISA reporting);
  • Implement corrective actions where appropriate; and
  • Analyse complaint trends to identify systemic quality issues.

Trending analysis must be performed at least annually and documented in the PMS report.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

Complaint investigations must be completed within 30 days for standard complaints; serious adverse events must be investigated urgently (within 24-48 hours of identification). All complaints classified as adverse events or technical complaints must be reported to NOTIVISA in accordance with RDC 753/2022.